Psoriasis Clinical Trial
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).
Full Description
This is a multi-center (more than one clinical site will work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study to determine the efficacy and safety of guselkumab in participants with PsA. The study will consist of 4 parts: Screening period (6 weeks), a double-blind treatment period (consists of guselkumab and placebo treatment for 24 weeks), an active treatment period (guselkumab for 20 weeks), and follow-up period (12 weeks). The maximal study duration for a participant will not exceed 62 weeks including the Screening period. Eligible participants will be randomly assigned to one of two groups in a 2:1 ratio to either receive Guselkumab 100 milligram (mg) at Weeks 0, 4 then every 8 weeks or Placebo at Weeks 0, 4 then every 8 weeks until Week 24. At week 24, participants remaining in the placebo group will start to receive guselkumab 100 mg at Weeks 24, 28, 36 and 44. Participants in both treatment groups who have less than (<) 5 percent (%) improvement from baseline in both tender and swollen joint counts at Week 16 will qualify for early escape and will switch to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication in the particular country of study. The efficacy will be assessed primarily by measuring percentage of participants who achieve an American College of Rheumatology (ACR) 20 Response at Week 24. Participants' safety will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria:
Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
Had active PsA as defined by:
At least 3 swollen joints and at least 3 tender joints at Screening and at baseline
C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline
Has active PsA despite current or previous non-biologic disease-modifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable
Exclusion Criteria:
Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
Has previously received guselkumab or ustekinumab
Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug
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There is 1 Location for this study
Huntsville Alabama, , United States
Trumbull Connecticut, , United States
Clearwater Florida, , United States
Tampa Florida, , United States
Sandy Springs Georgia, , United States
Indianapolis Indiana, , United States
Boston Massachusetts, , United States
Edina Minnesota, , United States
Saint Louis Missouri, , United States
Wyomissing Pennsylvania, , United States
Jackson Tennessee, , United States
Arlington Virginia, , United States
Barrie Ontario, , Canada
London Ontario, , Canada
Peterborough Ontario, , Canada
Waterloo Ontario, , Canada
Berlin , , Germany
Hamburg , , Germany
Herne , , Germany
Kiel , , Germany
Köln , , Germany
Lubeck , , Germany
Bialystok , , Poland
Elblag , , Poland
Poznań , , Poland
Warszawa , , Poland
Bucharest , , Romania
Bataysk , , Russian Federation
Moscow , , Russian Federation
Novosibirsk , , Russian Federation
Ryazan , , Russian Federation
Saratov , , Russian Federation
St. Petersburg , , Russian Federation
Ufa , , Russian Federation
Ulyanovsk , , Russian Federation
Yaroslavl , , Russian Federation
Barcelona , , Spain
Madrid , , Spain
Sabadell , , Spain
Santiago de Compostela , , Spain
Sevilla , , Spain
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